MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLEARCUT KNIVES; KNIFE, OPHTHALMIC

Catalog Number	8065982865
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that an ophthalmic cutting blades were found dull and could not complete the incision.The surgery was completed with a replaced blade with no impact to the patient procedure details was not reported.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.Three opened 2.8 clearcut hp2 knives, without sheathing and blade exposed, in a blister, were received for the report of dull blades.Samples 1, 2 and 3 were visually inspected and found to be nonconforming, blades had bent tip and damaged cutting edge.Penetration testing could not be performed due to the damage of the samples.A review of the device history record traceable to the possible lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The exact root cause could not be determined from the investigation performed.The damage to the returned samples is consistent with damage that can occur when the blade contacts a hard surface such as the protective blade tray when product is improperly removed or inserted after use, or improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint samples could have contributed to the customers reported issue of dull knives.The exact root cause for the damaged knives samples is unknown, therefore specific action with regards to this complaint cannot be taken.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Any nonconformance, such as the damaged tip and damaged cutting edge exhibited on the returned opened samples, is removed from the lot and scrapped.Functional penetration testing is performed and monitored during the finishing process to ensure the sharpness of the product.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLEARCUT KNIVES
• Common Device Name: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20177849
• Report Number: 2523835-2024-02060
• Device Sequence Number: 15528324
• Product Code: HNN
• UDI-Device Identifier: 00380659828652
• UDI-Public: 00380659828652
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065982865
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown